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In this module, you will learn about determining eligibility criteria for clinical trials and how patients are selected to participate. Approaches to maximising compliance and retention in trials are discussed to ensure complete and accurate data collection. You will learn about clinical pathways, such the steps from how patients are initially referred, to screening and tests to confirm eligibility, to enrolment and treatment. You will also learn how data is collected, protected and managed in clinical trials and you will be given the opportunity to learn more about the diverse professional roles involved in these tasks, including virtual visits with UCLH Staff. You will learn about the pathology of certain diseases and how translational research is being integrated into trials to allow for the development of personalised medicine. Additionally, you will gain important insights into how to identify, address and reduce the inequalities in clinical trial access across many underserved populations, alongside learning about the barriers to clinical trial recruitment and retention related to socioeconomic status, ethnic minority and demographics. Finally we will discuss about the role of social science and Patient and Public Involvement and Engagement in Clinical trials.

At the end of this module you will be able to:

1. Propose methods to encourage participation in clinical trials by being able to recognise and describe motivations for, and barriers to, participation in trials (at individual and societal levels).
2. Recommend methods to ensure maximum compliance with treatment and follow-up within a trial protocol.
3. Explain the patient (and data) pathway throughout a clinical trial from screening, through treatment, follow-up and after trial care.
4. Describe the alignment and integration of translational/biological research into clinical trials to enable personalised/stratified treatment (including an introduction to the biology of disease where appropriate).
5. Understand the role of social science in clinical trials and how qualitative and quantitative study designs can complement each other.

Locock, et al. (2011) Personal benefit, or benefiting others? Deciding whether to take part in clinical trials. Clinical trials 8(1), pp.85-93

Drolet et al. (2011) Translational Research: understanding the continuum from bench to bedside. Transl Res. 157(1), pp.1-5.

Johnson, et al. (2007) Toward a definition of mixed methods research. Journal of Mixed Methods Research 1(2), pp.112-133